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Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial
Umeå universitet, Medicinska fakulteten, Institutionen för klinisk vetenskap, Obstetrik och gynekologi.ORCID-id: 0000-0002-7865-4560
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2019 (Engelska)Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, artikel-id 10Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Background

There is a great need for a prospective randomized trial to evaluate the risks and benefits of opportunistic salpingectomy. Recently, genetic and morphologic studies have indicated that epithelial ovarian cancer predominantly develops in the Fallopian tubes. Consequently, there is reason to believe that salpingectomy would reduce the risk of ovarian cancer. Studies on reducing the risk of ovarian cancer have compared indicated salpingectomy with no salpingectomy, while studies on surgical safety as well as ovarian function after opportunistic salpingectomy have been small with a short follow-up. No study has reported menopausal symptoms.

Methods/design

In this national register-based randomized controlled trial, women <55 years old, planned for a hysterectomy for a benign cause, will be randomized to concomitant salpingectomy or no salpingectomy. The follow-up will be conducted according to already established routines within the register using on-line questionnaires. Primary outcomes have been defined for three different time points: short-term complications up to 8 weeks postoperatively (n = 2800), intermediate-term changes in menopausal symptoms measured by the Menopause Rating Scale at baseline and after 1 year (n = 1670), and long-term epithelial ovarian cancer assessed through national registers after 30 years (n = 5052) (or n = 7001 for high-grade serous cancer). In a sub-study of 75 women, ovarian function will be evaluated through change in anti-Müllerian hormone measured before surgery and after 1 year.

Discussion

Hysterectomy for a benign cause is a common surgical procedure and several national societies recommend salpingectomy while performing a benign hysterectomy, despite a lack of scientific evidence for the safety of the procedure. Sweden has unique conditions for clinical trials because of its national quality registers and health registers with excellent quality and near complete coverage. If no additional risks are associated with concomitant salpingectomy, it can be recommended at the time of benign hysterectomy to reduce the risk of epithelial ovarian cancer. If not, the risks and benefits must be balanced. The results of this study will be important for informing women undergoing a benign hysterectomy.

Trial registration

ClinicalTrials.gov, NCT03045965. Registered on 8 February 2017

Ort, förlag, år, upplaga, sidor
BioMed Central, 2019. Vol. 20, artikel-id 10
Nyckelord [en]
Ovarian cancer, Opportunistic salpingectomy, Early menopause, Hysterectomy, Complications, Menopausal symptoms
Nationell ämneskategori
Reproduktionsmedicin och gynekologi
Identifikatorer
URN: urn:nbn:se:umu:diva-155632DOI: 10.1186/s13063-018-3083-8ISI: 000454906300003PubMedID: 30611296OAI: oai:DiVA.org:umu-155632DiVA, id: diva2:1282693
Forskningsfinansiär
Cancerfonden, CAN 2017/464Tillgänglig från: 2019-01-25 Skapad: 2019-01-25 Senast uppdaterad: 2019-01-25Bibliografiskt granskad

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Idahl, Annika

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